NCT03651427

Brief Summary

Transgender women (male-to-female) were invited to participate in this study to test the impact of Cross-Sex Hormone Therapy (CSHT) in the brain. Neuroimaging and cognitive assessment were performed in different time-points to compare the impact of CSHT in the brain.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 13, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 29, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

August 24, 2018

Last Update Submit

August 27, 2018

Conditions

Gender Dysphoria

Keywords

Estradiol;Brainglutamatespectroscopyhypogonadism

Outcome Measures

Primary Outcomes (1)

  • Glutamate concentration in the left hippocampus

    Proton Spectroscopy - magnetic resonance imaging; Glutamate concentration in the left hippocampus will be primarily correlated to working memory scores.

    90 days

Secondary Outcomes (9)

  • Cortical Thickness

    90 days

  • Diffusion track imaging

    90 days

  • functional connectivity

    90 days

  • Glutamate concentration in the anterior cingulate cortex and left dorsolateral prefrontal cortex

    90 days

  • Cognition

    90 days

  • +4 more secondary outcomes

Study Arms (1)

Transgender Women

EXPERIMENTAL

Transgender women who already completed GAS or that agreed to start gonadotropin release hormone analogue to suppress endogenous sex hormones. If the participants were using CSHT in the moment of the study assignment, they were asked to stop hormones for 30 days to evaluate the impact of hypogonadism in the brain. After this first assessment, they received prescriptions for Estradiol (equine conjugated oestrogen, or estradiol valerate, or topic 17-beta estradiol formulations) for 60 days, and the impact of CSHT was evaluated again to compare to washout condition.

Drug: Estradiol

Interventions

EstradiolDRUG

Induced hypogonadism and re-institution of CSHT

Also known as: Drug washout
Transgender Women

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Transgender women
  • Age 18 to 60 years old.

You may not qualify if:

  • Use of psychostimulant drugs
  • Use of Antidepressive, Mood Stabiliser, Anti-psychotic, Benzodiazepines, anti-convulsivants, Anorexigenic
  • Endocrinological disease (other than diabetes)
  • Arterial Hypertensive Disease of Diabetes Mellitus out of control target
  • Neurological disease, including stroke or recent cranial trauma with loss or consciousness
  • HIV with low CD4 or high viral charge or symptomatic AIDS
  • Neoplasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

RECRUITING

Related Publications (1)

  • Salgado JV, Malloy-Diniz LF, Abrantes SS, Moreira L, Schlottfeldt CG, Guimaraes W, Freitas DM, Oliveira J, Fuentes D. Applicability of the Rey auditory-verbal learning test to an adult sample in Brazil. Braz J Psychiatry. 2011 Sep;33(3):234-7. doi: 10.1590/s1516-44462011005000007.

    PMID: 21971775RESULT

Related Links

MeSH Terms

Conditions

Gender DysphoriaHypogonadism

Interventions

Estradiol

Condition Hierarchy (Ancestors)

Sexual Dysfunctions, PsychologicalMental DisordersGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

EstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Maria Lobato, Dr

    Hospital de Clínicas de Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maiko Schneider, MD

CONTACT

5551997722606maikoschneider@hcpa.edu.br

Fernanda Rohrsetzer

CONTACT

51999614503fcunegatto@hcpa.edu.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Sel-controlled case series
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2018

First Posted

August 29, 2018

Study Start

February 13, 2017

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

August 29, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)